FDA Workshop on Autonomous Robotic Medical Devices

FDA is planning to hold a two-day public workshop 12/2-3 to examine the benefits and risks of robotic medical devices capable of autonomous operation or remote teleoperation, potentially informing future regulatory policy for the emerging technologies.

The CDRH hybrid workshop is intended to bring together device manufacturers, healthcare providers, patients and regulatory professionals to discuss technical considerations, user experiences and patient safety.

Discussions will focus on terminology, the potential benefits and risks of autonomous and remotely operated robotic systems, and considerations for future policy development that balances technological innovation with reasonable assurance of safety and effectiveness.

The workshop comes on the heels of the agency’s September draft guidance on premarket submissions for robotically assisted surgical devices, which does not specifically address autonomous or remotely teleoperated surgical systems (see earlier story).

More information on the meeting can be found here.